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Job Details

Regulatory and Site Services Specialist (M/W)

Company: Chiltern
Location: Poland - Warsaw
Reference: CS900093
Closing Date: 21 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Our successful and dynamic team in Poland is currently looking to expand

Requirements:

Job Background

We are looking to recruit Regulatory and Site Services Specialist 


About the department: This department provides an efficient, quality-centric approach to study startup activities with a growing focus on site relationships. RSS perform regulatory and ethics submissions (initial and amendment), document collection and quality control through all phases of the clinical trial, and execution of site level feasibility in coordination with the Feasibility department.  There are opportunities to develop your career, take on more responsibilities and be involved in cutting edge global studies.

Duties & Responsibilities:

• Perform / Assist in the development of Informed Consent Forms, labels and other patient facing material in accordance with country-specific requirements.
• Coordinate and/or perform the preparation, quality control review, and submission of CTA packages including initial submission, amendments and End of Trial Declarations as well as non-substantial notifications, status reports etc. to the CA and IRB/IECs and to any other country specific authority/body in assigned countries (except FDA).
• Prepare and respond to Competent Authority (CA) and Ethics Committee (EC)/Institutional review Boards (IRB) and to any other country-specific authority/body after Regulatory Project Lead/Manager approval.
• Develop and produce metrics and status reports to support the needs of Project Managers, line management, and other senior-level department colleagues.
• Facilitate/participate in training programs and department meetings.
• Provide input to Requests For Information (RFIs), Requests for Proposals (RFPs) and bid defence presentations as required.

Requirements:
• Bachelor’s degree in life sciences, related discipline or experience in the role.
• Proven working knowledge of Study Start Up activities in Poland
• Experience of the clinical research process and terminology
• Experience using a clinical trial management system
• The successful candidate will be a strong communicator, who has a great eye for detail and excellent organizational skills. You will have the ability to work independently and as a part of a team.

Additional Information:
For a confidential discussion about this opportunity, please phone +33 1 41 05 73 38
To apply, please send your CV to Christelle.segabiot@chiltern.com
Please note that if your experience does not mirror that of our requirements for this role you may not receive a response
No agency submissions will be considered
For more information about Chiltern, please visit our web site at www.chiltern.com



Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

On application

Position Type

Permanent
Full Time

Contact

Email Christelle Segabiot - christelle.segabiot@chiltern.com
+33 1 41 05 73 38

Apply for this job: Regulatory and Site Services Specialist (M/W)

Contact Information:

Address:  France
37 bis rue de Villiers, 92200 Neuilly sur Seine, France

France
Tel:  +33 1 41 05 73 00
Fax:  +33 1 41 05 73 01
Website:  Visit Our Web Site

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